BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790592 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15045
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    November 13, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL ELECTROGRAM (AEGM) HAD "STATIC" OR A NOISY BASELINE SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT HAD A MAZE PROCEDURE PRIOR TO IMPLANT. ALTHOUGH THERE APPEARS TO BE NOISE, THE DEVICE IS SENSING ONLY THE P WAVES. ALL OTHER MEASUREMENTS ARE WITHIN NORMAL LIMITS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL ELECTROGRAM (AEGM) HAD "STATIC" OR A NOISY BASELINE SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT HAD A MAZE PROCEDURE PRIOR TO IMPLANT. ALTHOUGH THERE APPEARS TO BE NOISE, THE DEVICE IS SENSING ONLY THE P WAVES. ALL OTHER MEASUREMENTS ARE WITHIN NORMAL LIMITS. THE LEAD REMAINS IN USE. IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING REMOVED DUE TO A SYSTEM UPGRADE. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR